Hello all,
As you can see from the caption, I am confused that if all ME equipments with software shall be evaluated according to IEC 60601-1-4 or clause 14 (PEMS) which specified in 3rd edition? From the standard/clause title, the programmable electrical medical system clearly applies. However, what does the "programmable" mean? If the software burned into the MCU and can not be modified by user also needs to be taken into account? Please kindly advise it.
Thanks in advance.
Roland
As you can see from the caption, I am confused that if all ME equipments with software shall be evaluated according to IEC 60601-1-4 or clause 14 (PEMS) which specified in 3rd edition? From the standard/clause title, the programmable electrical medical system clearly applies. However, what does the "programmable" mean? If the software burned into the MCU and can not be modified by user also needs to be taken into account? Please kindly advise it.
Thanks in advance.
Roland